Portable Driving Simulator for Neurological Conditions

Overseen By Abiodun E Akinwuntan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Portable Driving Simulator for Neurological Conditions?

Research shows that driving simulators can be effective in improving driving skills and cognitive functions in people with neurological conditions like Parkinson's disease. Patients have found simulators to be motivating and informative, and studies have shown improvements in driving performance and decision-making skills after simulator training. ^{1 2 3 4 5}

Is the Portable Driving Simulator safe for use in humans?

The available research on driving simulators, including studies on neurological conditions like Parkinson's disease and acquired brain injury, suggests that these simulators are generally safe for use in humans. They have been used in various studies to assess driving ability and train drivers, with no significant safety concerns reported. ^{6 7 8 9 10}

How is the Portable Driving Simulator treatment different from other treatments for neurological conditions?

The Portable Driving Simulator is unique because it uses interactive driving scenarios to assess and rehabilitate driving skills in neurological patients, offering a motivating and effective alternative to traditional methods. Unlike standard treatments, it provides a safe, controlled environment to evaluate and improve driving abilities, which is particularly beneficial for patients recovering from brain injuries or diseases. ^{1 2 6 7 9}

What is the purpose of this trial?

The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator.

Research Team

Abiodun Akinwuntan, PhD, MPH MBA

Principal Investigator

University of Kansas School of Health Professions

Eligibility Criteria

This trial is for individuals with a first-ever stroke, Parkinson's disease (PD), or multiple sclerosis (MS) who have valid driver's licenses and at least 3 years of driving experience. They must score ≥24 on the Mini-mental State Examination and have binocular acuity meeting Kansas driving laws.

Inclusion Criteria

Mini-mental State Examination score ≥24, and

I have been diagnosed with stroke, Parkinson's disease, or multiple sclerosis for the first time.

I have a valid driver's license and over 3 years of driving experience.

Exclusion Criteria

I have a brain injury or another neurological condition, but not stroke, Parkinson's, or MS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-training Evaluation

Participants undergo driving-related physical, visual, and cognitive tests

1 week

1 visit (in-person)

Training

Participants receive five hours of simulator training to improve driving skills

2 weeks

5 visits (in-person)

Post-training Evaluation

Participants undergo a post-training evaluation similar to the pre-training evaluation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any long-term effects or improvements in driving skills

4 weeks

Treatment Details

Interventions

• Portable Driving Simulator

Trial Overview The study compares a low-cost portable driving simulator (PDS) to a high-fidelity fixed-base simulator in retraining driving skills. Participants will be randomly assigned to one of these tools for training and evaluated before and after the sessions.

Participant Groups

Group I: Low-Fidelity PDS Training Experimental Treatment 1 Intervention

Individuals with stroke, PD, or MS

Group II: High Fidelity Fixed-Base Simulator Training Active Control 1 Intervention

Individuals with stroke, PD, or MS

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

A systematic review of 12 studies involving driving simulators for stroke patients identified three main categories of driving scenarios: vehicle controls, hazard perception, and trajectory planning, with simple navigation and emergency stop being the most common scenarios used.

The review highlights the need for future research to include more complex driving conditions, such as varying weather and localized traffic situations, to better assess the driving capabilities of stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving scenarios and environmental settings in simulator-based driving assessment systems for stroke: a systematic review. Chanmas, G., Taveekitworachai, P., Paliyawan, P., et al.[2023]

A study involving 56 neurological patients showed that the newly installed driving simulator at the Neurological Rehabilitation Centre was positively received, indicating good patient acceptance of this rehabilitation method.

Patients found the driving simulator to be motivating, effective, and informative, which is crucial for its successful implementation in assessing and rehabilitating driving ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interactive driving simulation--a new approach to diagnosis and rehabilitation of driving skills]. Wolbers, T., Küst, J., Karbe, H., et al.[2006]

A pilot study involving four drivers with Parkinson's disease showed that a rehabilitation program using a driving simulator led to a reduction in crashes and improved decision-making skills during simulated driving scenarios.

Three out of four participants demonstrated significant improvements in their driving performance on a standard road test after the training sessions, indicating that simulator training may be a beneficial intervention for drivers with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DRIVER REHABILITATION IN PARKINSON'S DISEASE USING A DRIVING SIMULATOR: A PILOT STUDY. Uc, E., Rizzo, M., Anderson, S., et al.[2021]

The driving simulator provides a safe and effective way to assess driving aptitude in patients with physical and cognitive deficits, showing a high correlation with real-world driving assessments (kappa=0.81; P<0.0001).

Medical experts tend to rely more on the results from the driving simulator than on neuropsychological evaluations, which have lower sensitivity and specificity (55% and 80% respectively), indicating that the simulator may offer a more accurate reflection of a patient's driving capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relevance of a driving simulator in the assessment of handicapped individuals]. Carroz, A., Comte, PA., Nicolo, D., et al.[2019]

A pilot study involving 15 participants with Parkinson's disease showed that 10 hours of training in a high-fidelity driving simulator significantly improved on-road driving skills, with all participants who initially failed the road test passing after training.

Cognitive functions related to driving also improved, as evidenced by significant enhancements in scores on the Montreal Cognitive Assessment and the Dot Cancellation test, suggesting that simulator training may benefit both driving ability and cognitive skills in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a driving simulator to improve on-road driving performance and cognition in persons with Parkinson's disease: A pilot study. Devos, H., Morgan, JC., Onyeamaechi, A., et al.[2017]

Patients deemed fit to drive after a traffic medical assessment performed worse on cognitive tests compared to established norms, indicating potential concerns about their driving fitness.

The CyberSiM driving simulator showed that a high percentage (75-95%) of patients fell within the suggested cut-off limits for driving ability, suggesting it may be a useful tool for assessing driving fitness alongside cognitive tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of Norm Values on Results from a Simulator Device and Cognitive Tests in Traffic Medicine. Samuelsson, K., Wressle, E.[2022]

The study involving 91 neurological patients demonstrated that driving simulators can effectively differentiate between fit and unfit drivers based on reaction times and driving behaviors across various environments, highlighting their potential as assessment tools.

Unfit drivers showed significant issues such as greater variability in steering and more collisions in urban settings, while conditionally fit drivers did not exhibit clear differences from fit drivers, indicating the need for careful human judgment in their evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring driving characteristics of fit- and unfit-to-drive neurological patients: a driving simulator study. Motnikar, L., Stojmenova, K., Štaba, UČ., et al.[2020]

In a pilot study involving eight drivers with Parkinson's disease, a simulator training program showed a trend towards reduced crashes and significantly improved reaction times to potential crash risks over three driving sessions.

These results suggest that simulator training may be a feasible and beneficial intervention for improving driving safety in individuals with Parkinson's disease, warranting further research to explore its long-term effects and comparisons with standard driver education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COLLISION AVOIDANCE TRAINING USING A DRIVING SIMULATOR IN DRIVERS WITH PARKINSON'S DISEASE: A PILOT STUDY. Dawson, JD., Rizzo, M., Anderson, SW., et al.[2021]

A pilot study involving 22 individuals with acquired brain injury showed that eight sessions of driving simulator training, in addition to usual care, resulted in a significant increase in driver confidence compared to those receiving only usual care.

Despite the positive change in confidence, the simulator training did not lead to a significant improvement in on-road driving performance, with 50% of participants in the simulator group failing the on-road assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating feasibility and preliminary efficacy of a simulator-based driving intervention for people with acquired brain injury: A randomised controlled pilot study. Dimech-Betancourt, B., Ponsford, JL., Charlton, JL., et al.[2022]

In a study involving 30 healthy subjects, the driving simulator (CRCDS Mini-Sim) effectively detected impairment in driving ability caused by 7.5 mg of zopiclone, a hypnotic medication.

The administration of zopiclone resulted in a significant increase in the standard deviation of lateral lane position (SDLP) by 2.62 cm, indicating impaired driving, which aligns closely with results from traditional on-the-road driving assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. Simen, AA., Gargano, C., Cha, JH., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Driving scenarios and environmental settings in simulator-based driving assessment systems for stroke: a systematic review. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Interactive driving simulation--a new approach to diagnosis and rehabilitation of driving skills]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

DRIVER REHABILITATION IN PARKINSON'S DISEASE USING A DRIVING SIMULATOR: A PILOT STUDY. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Relevance of a driving simulator in the assessment of handicapped individuals]. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Use of a driving simulator to improve on-road driving performance and cognition in persons with Parkinson's disease: A pilot study. [2017]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Usability of Norm Values on Results from a Simulator Device and Cognitive Tests in Traffic Medicine. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Exploring driving characteristics of fit- and unfit-to-drive neurological patients: a driving simulator study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

COLLISION AVOIDANCE TRAINING USING A DRIVING SIMULATOR IN DRIVERS WITH PARKINSON'S DISEASE: A PILOT STUDY. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Investigating feasibility and preliminary efficacy of a simulator-based driving intervention for people with acquired brain injury: A randomised controlled pilot study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. [2020]